Quantification of Endogenous Biomarkers in Biological Matrices
The quantitation of endogenous compounds in biological methods requires reliable validated assays. Using the required surrogate reference standard (in most cases a recombinant reference standard that allows the relative quantitation of the endogenous analyte) can be challenging. To assess the suitability of the reference standard you need to demonstrate acceptable parallelism between the endogenous analyte and the calibration curve upon multiple dilutions. Our team can help!
Download this insert to find out more about the approaches used by Altasciences to validate and monitor assay performance.
Contact our bioanalytical scientists today for your customized experience.
You may also be interested in the following:
- Webinar: Certificate of Analysis Essentials for Regulated Bioanalysis
- Webinar: Selectivity, Selectivity, Selectivity — a New Dimension by Differential Mobility Spectrometry
- Webpage: Bioanalytical Assay List
- Webpage: Translational Biomarkers
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Leveraging the Benefits of Microsampling for Safety and Convenience
In a previous blog, we provided an overview of microsampling technology for preclinica
The Lancet: Findings from a Phase I study completed by Altasciences and Novo Nordisk A/S to determine the safety, tolerability, pharmacokinetic, and pharmacodynamics of a drug combination for weight management
25+ Years’ Experience Conducting Early Phase Drug Development
One of the most significant milestones in drug development research is the transition from preclinical to clinical studies. Ensuring risk mitigation at all steps of preclinical and clinical testing, as well as incorporating a thorough safety review plan in the clinical setting, is integral.
Altasciences applies recommendations from world-wide regulatory agencies to ensure that studies are conducted safely, ethically, and in a scientifically robust manner.
We facilitate drug development and save you time by:
- Preparing your preclinical study designs, including species selection and dose level determination.
- Conducting the required safety testing and updating your Investigational Brochure while your IND/CTA-enabling studies are in progress.
- Writing your IND/CTA applications.
- Planning your clinical program while your preclinical safety assessment is ongoing so that you can initiate your first-in-human (FIH) trials as soon as you receive regulatory approval.
- Designing your FIH clinical protocol using preclinical study data, including identifying the maximum safe starting doses.
- Timing small-scale drug formulations with clinical conduct to get your trials started sooner.
- Conducting your FIH trials and making quick, informed dosing decisions based on timed bioanalytical data and safety data available within 48 hours.
- Quickly identifying trial findings that may allow you to waive certain studies or provide critical data for safety/dosing considerations in subsequent clinical studies.
Our preclinical, manufacturing, bioanalytical, and clinical teams work closely together to transition drugs through the critical early phases of drug development.
Speak with our experts.
You may also be interested in the following:
- Video: Your Road to Proactive Drug Development with Altasciences
- Webpage: Scientific, Regulatory and Strategic Guidance
- Webpage: Full-Time Equivalent (FTE) Capabilities
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
Integrating Anatomic and Clinical Pathology
Anatomic and clinical pathology datasets are critical when evaluating safety and efficacy during the preclinical stage of drug development. They identify and characterize toxicity by different, yet complementary means. Our expertise in integrating both clinical and pathology datasets provides a more comprehensive assessment for predicting important toxicities that could occur in humans.
At Altasciences, our Anatomic Pathologists and dual-certified Anatomic and Clinical Pathologist bring many decades of combined drug development knowledge to support our integrated approach to safety evaluation.
Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining solutions, whether a single study or multiple programs, to offer an integrated/synchronized approach to CRO and CDMO services from lead candidate selection to clinical proof of concept, and beyond.
You may also be interested in the following:
- Fact Sheet: Preclinical Drug Development
- Fact Sheet: Small Molecule Safety Assessment
- Fact Sheet: Biologics Safety Assessment
- Video: Altasciences’ Animal Welfare Program
- Webinar: 2020 SEND Progress Update